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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: software salesperson who wrote (8256)5/5/2003 6:07:39 PM
From: Biomaven  Read Replies (3) | Respond to of 52153
 
Looks like the "new FDA" properly ignored Wolfe and approved Iressa. Iressa doesn't work that often, but when it does, it can be miraculous. Why Wolfe thinks patients and their doctors should be "protected" from this chance at a dramatic recovery is beyond me.

Here's an interesting postscript:

Genetic Test For Iressa On Horizon
Matthew Herper, 05.05.03, 4:21 PM ET

NEW YORK - AstraZeneca's Iressa can help patients recover from lung cancers that would otherwise be deadly. Unfortunately the drug, which was approved by the Food and Drug Administration today, works only in 10% of patients. To make matters worse, doctors don't have diagnostic tests that can identify which patients will be helped.

Ronald Natale is working to change that. Natale, the director of the national lung cancer research program for the Salick Health Care subsidiary of AstraZeneca (nyse: AZN - news - people ) and acting medical director at Cedars-Sinai Cancer Center, says a preliminary study may help select which patients will be helped by the drug. The results, he says, will be presented in full at the upcoming annual meeting of the American Society of Clinical Oncology in Chicago.
 
Natale says he and his colleagues looked at 50 patients who were given Iressa. Thirteen of these people had major responses to the drug, meaning their lung tumors were suppressed. Natale and his colleagues used DNA microarrays to compare tumors that were hurt by the drug with those that weren't. Their preliminary evidence suggests a genetic profile that may predispose a response to the drug.

"We have to conduct a prospective validation study," Natale says, "but within a year or so we hope to have a single assay that may be helpful."

That's very good news, because in patients who respond, doctors say Iressa is an incredibly powerful drug. "I've had patients who have gone from being on oxygen to skiing at altitude," says Thomas Lynch, medical director of thoracic oncology at Massachusetts General Hospital, "and that doesn't happen with chemotherapy."

Right now, Lynch says, it is not clear what causes some patients to respond and others not to. "We wish we knew who responded to it in advance," he says.

Iressa has been closely watched partly because it targets the same pathway as Erbitux, being developed by ImClone Systems (nasdaq: IMCLE - news - people ) and Bristol-Myers Squibb (nyse: BMY - news - people ), and Tarceva, being developed by OSI Pharmaceuticals (nasdaq: OSIP - news - people ), Genentech (nyse: DNA - news - people ) and Roche. It is possible that genetic tests might be helpful in those drugs as well.


forbes.com

Peter